Identity
- Trade Name
- MALE CATH EUDAMED
- Device Name
- Male External Catheter EUDAMED
- Model / Reference
- GS 1010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265101034 EUDAMED08907265101027 EUDAMED08907265101010 EUDAMED08907265101003 EUDAMED
- Basic UDI-DI
- 8907265A001Y3 EUDAMED
- EMDN Code
- U070201 SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Male Cath by Romsons Group Private Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8907265A001Y3 | Class I | Active |
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Manufacturer
- Manufacturer
- Romsons Group Private Limited
- EUDAMED SRN
- IN-MF-000036506
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (4)
- EUDAMED b6ebe800-d87d-4836-a67e-6039b42a609a 61 fields · synced Aug 2, 2026
- EUDAMED d97c60e9-4927-49ed-a99c-e8809c0a778d 61 fields · synced May 16, 2026
- EUDAMED 621e4170-7c05-42bf-817b-dda9190a3b41 61 fields · synced May 17, 2026
- EUDAMED 9fb96d37-fa05-458e-a6a5-78b9bad83821 61 fields · synced May 19, 2026